California ecig “regulation” hearing: a catalog of lies (part 2)

by Carl V Phillips

Continuing from the previous post, you will recall that we established that California Senator Mark Leno is absolutely hilarious when he tries to talk about science — assuming you can maintain a sense of humor about someone who is spouting lies in support of a bill that would inflict a great deal of harm with no apparent benefits. He continues by suggesting he also does not understand how lawmaking works, or even his own bill. Sadly, it is not nearly as funny as his attempts to talk science.

And the reason we want to include in the STAKE Act, which, again, is the Stop Tobacco Access to Kids Enforcement Act, is that we know that this is in the hands of children, and we want to increase enforcement and oversight provisions of the Act, so—which do not currently apply to e-cigarettes.

E-cigarette sales to minors are already banned. So what is it in California’s cutesy-named tobacco control law that will make that work better? I suppose there might be some other provisions in the law that are aimed at stopping teenagers from using the product, but it is funny that Leno did not mention any of them. He keeps making breathless claims about teenagers using e-cigarettes and waving his hands about doing something about it, but never once does he even assert — let alone establish — that some provision will accomplish that. Either he is auditioning to be a public health professor or this legislation really has nothing to do with what he is claiming and he is hiding his real agenda.

So you’re going to hear from different resources, including researchers from the University of California, San Francisco.

No content there, but I wanted to point out that it is refreshing that Leno makes clear he is one of those oligarchs who divides the rest of humanity into three categories: enemies, “resources”, and serfs (h/t @broonyIam).

We have information from not only the California Department of Public Health, which has declared these devices to be dangerous and unsafe, and they are currently in the midst of an educational campaign. You may have seen some of the television commercials that are out right now.

Again, no content, other than his weak grasp of the words “information” and “educational”. The Orwellian disinformation campaign that he refers to is a horrific violation of the public trust. The description of it as “educational” constitutes about a hundred more lies-by-reference from Leno.

The Federal Drug Administration [sic] already defines these products as tobacco products. The federal definition for tobacco products is, “the term ‘tobacco product’ means any product made or derived from tobacco that is intended for human consumption, including any component, part, or accessory of a tobacco product.” That which is vaporized is nicotine, which comes from tobacco. So it’s already recognized as, under federal definition, a tobacco product. We want to put it into statute here.

So his legal rationalization for this harmful bill is just as much clueless lying as his scientific rationalization. Not surprising, I guess. FDA CTP is in the process of asserting that they have jurisdiction over e-cigarettes because the Tobacco Control Act (not the FDA itself) established a category definition that FDA interprets (not defines) as allowing that. That is a wee bit different from “the FDA already defines….”

More important, different laws do different things, and create different categorizations depending on their goals. These have only functional significance, in order to apply rules to particular targets, and are not definitions in any other sense. (E.g., a federal law once defined Lake Champlain as one of the Great Lakes in order to divert particular resources to Vermont; this did not make it one of the Great Lakes in any normal sense.) You would think a senator might know that. The fact that a federal law, which has particular effects, includes that categorization in no way argues that the California SMURF Act (or whatever that was), which has different effects, should include that same categorization. Indeed, the fact that the federal law includes that definition is not even an argument that the federal law itself should use that categorization (that is the is-ought fallacy).

(I am proud of myself for resisting a cheap joke about him not knowing what FDA stands for.)

And in addition to the Department of Public Health, federal—the Food and Drug Administration, also the World Health Organization, and then you’re going to hear from all the health advocacy groups, the Lung Association, the Heart Association, the Cancer Society. All those who are in the business of protecting public health will be speaking in support.

(Ok, he figured it out on his third try. Good for him.)

He got one word right there: “business”. These organizations, because they are first and foremost big businesses, are primarily concerned with their income stream. That income stream faces even greater threats from e-cigarettes than does the budget of California.

But you don’t have to just take it from me and from all these health advocacy groups that what I’m saying is so. I’m going to use some of the information that the e-cigarette industry itself has put out. And you should have all of this, these four pieces, distributed to you. I just want to walk you through them one by one.

So the first one I’m looking at is a warning label on MarkTen E-Vapor. MarkTen E-Vapor is one of the larger players in the market. And if you look at their advertisement, at the bottom, they have this warning: “This product is not intended for use by women who are pregnant or breastfeeding, or persons with or at risk of heart disease, high blood pressure, diabetes, or taking medicine for depression or asthma. Nicotine is addictive and habit forming, and it is very toxic by inhalation. Nicotine can increase your heart rate, blood pressure, and causes dizziness, nausea, and stomach pain. Inhalation of this product may aggravate existing respiratory conditions.” That’s from the industry itself.

So, apparently, Leno is saying that he takes his cues from Altria, and assumes everything they publish is correct.

Of course, given his lack of knowledge about e-cigarettes and the market, demonstrated in Part 1, he probably does not even know that he is quoting from Altria lawyers. It is even less likely that he understands the obvious purpose of this “warning”, even though he pretends to be an expert on regulation. The tobacco control industry has given the cigarette industry numerous gifts, like banning broadcast advertising (so they did not have to spend on expensive advertising in a largely zero-sum game of trying to take one another’s customers) and getting the states so invested in cigarette sales that they try to protect them. But none was a greater gift than the warning labels, which helped protect the industry from civil liability. So Altria was trying to come up with a label for their e-cigarettes that would provide that same benefit. For that purpose, does it matter to them if the claims are true? No, not at all — it only matters if they might provide a defense against some future lawsuit that the clever lawyers who wrote it could imagine.

Some have suggested that Altria’s pseudo-warning’s main purpose is to poison the well, sacrificing their own e-cigarettes to try to pull down the entire category, to the benefit of their much more lucrative cigarette market. It is easy to see why someone might offer that explanation, though if you understand just how beneficial the cigarette warning label has been for the major tobacco companies, it is clear that is a sufficient explanation. (To delve a little deeper: The requirements for the cigarette warning labels were especially good for the companies because they specified exactly what text was required, so in lawsuits plaintiffs could not later claim “yes, you said that, but you should have said more.” But that gift has not (yet) been bestowed for e-cigarettes, so the lawyers writing the “warning” label had to throw in everything they could think of to deal with that possible line of attack. It is really quite obvious what they are doing if you know the history.)

Of course, that does not excuse Altria. This label includes disinformation that is harmful to people’s health. And that is even more the case when it gets into the hands of a liar like Leno, who pretends that it is scientifically accurate and uses it to support a bill whose main impact would be to discourage smokers from switching to vaping. (Hmm, that does tend to make the poison-the-well story look more plausible, doesn’t it?)

Leno then goes on to reference Reynolds’s statements — because he believes everything they say too. He seems bizarrely fascinated by the fact that the traditional tobacco companies categorize e-cigarettes as a tobacco product. Do I even have to explain why this has even less relevance than the federal Tobacco Control Act categorization?

He then circles back to Altria’s statements:

“This product is not a smoking cessation product and has not been tested as such. California Proposition 65 Warning: This product,” MarkTen, an e-cigarette,—“This product contains nicotine, a chemical known to the State of California to cause birth defects or other reproductive harm.” And this is all coming from the industry.

Altria is not allowed to claim that their e-cigarettes are a smoking cessation product, but explicitly denying they are — even though it is obvious that they really are — is gratuitous and wrong. Unfortunately, lawyers will be lawyers. But even Altria does not actually endorse the silly California warn-about-everything law, as Leno lies. They merely attached it to cover all their bases.

And I’ll just close with what I think is a rather fascinating story, because when the opposition does come up–and, of course, they should be afforded their time…

Yes, so nice of the senators to graciously allow a single representative of the actual stakeholders, the only real expert in sight, almost 20% of the available time in the hearing, rather than giving Leno and his lying cronies all the time.

…they’re going to argue that they are not a tobacco product, that you should oppose this bill because it’s not a tobacco product, their own industry’s disclosures notwithstanding; that they are a cessation device, though they’ve never been tested or approved as a cessation device by the FDA or anybody else. It’s just their opinion.

Oh, that is a rich line, coming from someone who has been making up “facts” for ten minutes. It is just the opinion of the actual experts, based on extensive real-world evidence, that e-cigarettes are useful for smoking cessation. Apparently the experience of millions of people in the real world does not count as a test. Apparently Leno thinks it has never been tested whether California actually exists (sigh — a moment of wishful thinking there). It is the usual ANTZ lie, that only artificial and nearly useless contrived tests count as science. But Leno’s lie is compounded by the fact that some of those contrived and nearly useless tests have been done, and they have hinted at the very same result that we (much more robustly) get from looking at the real world.

As for his obsession about definitions, it is true that natural existential definitions are genuinely a matter of “just opinion”. His opinion is obviously that e-cigarettes are existentially tobacco products. Others disagree. But he is setting up that irrelevant observation as a strawman: People are arguing that his bill is bad not because of opinions about natural definitions, but because it does enormous harm without doing any apparent good. He got through his entire presentation without making a single claim that the law would have a benefit.

What this lawmaker does not seem to understand is that when you make laws, you define categories and these are chosen (in theory!) based on what would make for a good law. They can and often do differ from the natural existential definitions, even when those are largely matters of agreement — which is not even the case in this context. It does not matter what anyone’s opinion of the natural definition is, nor what other laws have defined. That has no bearing on the correctness of this bill. Moron.

But in 2009, NJOY, which is, again, one of the larger players in the e-cigarette market, at a time when Congress had not authorized the FDA to regulate tobacco products—all the FDA could regulate was cessation devices—so NJOY sued the Food and Drug Administration, claiming they were not a cessation device; they were a tobacco product. And they won. They won in court. And, in fact, the judge agreed and said in his own comments that, in fact, yes, they are a tobacco product and they are not a cessation device.

More lies, probably mostly due to Leno’s general cluelessness. NJOY did not initiate the suit; Smoking Everywhere did. The timing bit is technically true since NJOY joined the lawsuit in May and the Congressional authorization did not come through until June, but since the latter was already fait accompli when the suit was filed and nothing material happened until after it was final, this is obvious misleading. The “all the FDA could regulate was cessation devices” is wrong on many counts: First, FDA CTP still cannot regulate e-cigarettes as is implied by that. What FDA CDER tried to do was declare e-cigarettes unapproved drug delivery devices and ban them based on that — the smoking cessation role was largely irrelevant. And that was obviously not all they could do; they could have, say, done the right thing and not tried to ban them, on the basis that they were consumer goods, not pharmaceuticals — which of course became the law of the land after the lawsuit.

Leno continues his lying by mischaracterizing the plaintiffs’ positions and grossly mischaracterizing the ruling. The ruling by Judge Leon (amazing what a difference in intelligence you get by switching two letters) left open the possibility that FDA could regulate e-cigarettes under the Tobacco Control Act; his ruling did not declare them to be tobacco products. As should be obvious to even someone unfamiliar with the case, the judge would not and did not rule that they were not smoking cessation devices. That would be absurd. What he ruled is that FDA could not regulate them as pharmaceuticals unless they were being marketed as pharmaceuticals, such as by making smoking cessation claims, in which case FDA could.

Did I mention: “moron”?

So now that it’s more convenient for the industry to say they are a cessation device, they want to walk back from their own lawsuit, which they won, which determined that they were a tobacco product. But if they ever are, and it’s their right to apply to the FDA to be tested and approved as a cessation device, if and when that should ever happen, this bill will not impact them because this bill does not regulate cessation devices.

OMFG. The industry cannot say they are a smoking [he keeps leaving out that rather important word] cessation device, even though they are. That is what the ruling he was just talking about established. “The industry” did not file the lawsuit; two companies did. There is no such actor as “the industry”. Companies obviously would love to be able to make the truthful health claims about their products but cannot. No one argued or ruled that they were not smoking cessation devices; that was not relevant to the case. A ruling on whether such marketing claims can be made (as opposed to what is the obvious truth) would only come if someone submitted to FDA CDER, which is not going to happen. But, putting the lie to Leno’s continuing hollow rhetoric, there is no realistic possibility that anyone would try to go down that path.

A more subtle point that may not be widely realized by casual observers — but anyone making pronouncements about this like Leno certainly should know — is that official “smoking cessation device” status from FDA CDER would apply only to a particular product, not the category. Imagine that one manufacturer had such CDER approval that their product was an official smoking cessation aid. Another manufacturer selling an identical product would not be able to make the same claims even though what is true for one is obviously true for the other. The existence or lack of the approval does not change the worldly truth.

Moreover, this is a total fantasy scenario because the approval process would cost many millions of dollars for a single product and all it would allow is for the manufacturer to openly state what educated people all already know. It would take years and the manufacturer would not be able to upgrade the product without starting over to seek a new expensive approval, so the rest of the category would continue to improve and the approved product would be an unwanted dinosaur by the time the process was complete. So it would be insane to pursue this “option”. The drug approval process is designed for manufacturers of patented pharmaceuticals, to allow them to sell the product for an outlandish profit once they have approval. It would not work at all for any consumer good that exists in a competitive market, let alone an evolving technology.

Most important in all of this is the lie-by-innuendo that permeates what he is saying, that he is trying to insinuate into the audience without actually speaking the overt lie: It is not industry that cares most about this punitive bill; it is consumers. It is they, not companies, who will have to go outside to vape for absolutely no good reason. It is they, not companies, that will pay the punitive taxes that are the inevitable next step if this passes. Yes, the ecig-only companies will lose some business as a result of smokers being encouraged to just keep smoking, so they obviously do not like this. But it is much worse for the consumers. Moreover, the cigarette companies who are in the e-cigarette business — those companies that Leno is so obsessed with — will almost certainly gain as a result, selling enough more cigarettes to more than make up for their loss in e-cigarette sales. Leno would like to trick the audience into believing that what he is doing is good for the people and only bad for businesses, but it is actually terrible for the people and close to a wash for the industry as a whole.

There ends Leno’s “contribution” to this debate. The only way it could have been worse is if it were longer, since he was maintaining an impressive pace of more than one lie per sentence (even excluding those he incorporated by reference). He then turned it over to his tobacco control puppet masters whose lies are much more practiced and calculated, in contrast with Leno’s lies which seemed to be mostly a result of him not having a clue what he was talking about. Only 9.5 pages to go. This is truly horrifying.